Takeda Pharmaceuticals and its wholly-owned subsidiary, Takeda Pharmaceuticals North America announced that the U.S. Food and Drug Administration (FDA) has approved EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults.

EDARBYCLOR is the only fixed-dose therapy in the U.S. to combine an angiotensin II receptor blocker (ARB) with the diuretic chlorthalidone in a once-daily, single tablet. The recommended starting dose is 40/12.5 mg and the maximum dose is 40/25 mg.

The two medications in EDARBYCLOR work to help lower blood pressure in patients with hypertension. Azilsartan medoxomil, marketed as EDARBI in the U.S., reduces blood pressure by blocking the action of angiotensin II, a vasopressor hormone that naturally exists within the body.

When EDARBI blocks the angiotensin II receptor, blood vessels can stay relaxed and open, and blood pressure can be reduced. Chlorthalidone reduces the amount of water in the body by increasing the flow of urine, which helps to lower blood pressure.

“Hypertension is a complex disease that affects one in three Americans. It is critical to control hypertension because lowering blood pressure has been shown to reduce the risk of serious health consequences, including stroke and heart attack.” – Domenic Sica MD Professor Internal Medicine Nephrology Virginia Commonwealth University Medical Center

“The approval of EDARBYCLOR provides an effective treatment option to lower blood pressure for appropriate patients with hypertension who may require a combination of drugs to help achieve blood pressure goals,” Sica said.

“In clinical studies, EDARBYCLOR demonstrated statistically significant blood pressure reductions compared to its respective monotherapies and was shown to be superior to the fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide at maximum respective doses.” – Paulos Berhanu MD Executive Medical Director Medical & Scientific Affairs Takeda

“It is our belief this innovative treatment helps reinforce Takeda’s family of cardiovascular therapies by providing a new option to help appropriate patients, regardless of age, gender or race, work toward reaching their blood pressure goals,” he said.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, patients should discontinue EDARBI or EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood.

Adverse reactions include fetal or neonatal jaundice and thrombocytopenia. In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, EDARBI can cause symptomatic hypotension. Patients with renal impairment should be monitored for worsening renal function.

In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with ACE inhibitors and ARBs has been associated with oliguria and azotemia and rarely with acute renal failure and death. In patients with renal artery stenosis, EDARBI and EDARBYCLOR may cause renal failure.

In patients with renal disease, chlorthalidone may precipitate azotemia. Consider withholding or discontinuing EDARBI or EDARBYCLOR if progressive renal impairment becomes evident.

The most common adverse reaction that occurred more frequently with EDARBI than placebo in adults was diarrhea (2 percent versus 0.5 percent). The adverse reactions that occurred at an incidence of greater than or equal to 2 percent of EDARBYCLOR-treated patients, and greater than azilsartan medoxomil or chlorthalidone, were dizziness and fatigue.

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